FDA inspection help

Get the right FDA inspection support now

Choose a fixed-price readiness review, a focused virtual mock inspection, Form 483 response help, rapid readiness assessment, or urgent FDA support.

FDA inspection help

Choose the right next step

$495

For: Teams that need a fast review before an inspection window, customer audit, or readiness meeting.
Client sends: SOP list, recent quality records, open CAPAs, inspection dates, and the main concern.
Scope: One focused document and readiness review with priority findings.
Timing: Written notes within two business days after materials are received.
What you get: Readiness risk summary and next-action list.
Limit: Does not include a full mock inspection or response drafting.

Buy the review, then send the intake details from the confirmation page.

$1,250

For: Quality, operations, and leadership teams preparing for FDA questions.
Client sends: Agenda, facility type, records to review, staff roles, and inspection concerns.
Scope: One virtual mock session covering records, interviews, inspection-room flow, and next steps.
Timing: 90-minute live session plus written findings.
What you get: Priority gap list, coaching notes, and readiness actions.
Limit: Does not include on-site walkthroughs or full remediation execution.

Buy the mock, then schedule the session and send intake details.

From $750

For: Companies that received a Form FDA 483 and need an outside review before responding.
Client sends: The Form 483, closeout notes, response draft if available, and the response deadline.
Scope: Confidential observation review, response structure, CAPA concerns, and evidence gaps.
Timing: Turnaround depends on observation count and deadline.
What you get: Response review notes and recommended corrections.
Limit: Final price is confirmed after the Form 483 is reviewed.

Request a confidential review and include the response deadline.

From $2,500

For: Sites with near-term inspection risk that need a broader readiness review.
Client sends: Facility type, product category, inspection history, records list, and target dates.
Scope: Remote or hybrid assessment of records, quality systems, staff readiness, and inspection flow.
Timing: Schedule and turnaround are set after the intake review.
What you get: Assessment report with ranked gaps and correction priorities.
Limit: Travel, on-site days, and remediation work are scoped separately.

Request assessment scope and availability.

Urgent support

For: Teams facing an active inspection, Form 483, Warning Letter, import hold, or deadline.
Client sends: FDA document type, deadline, current status, contact details, and immediate risk.
Scope: Rapid triage call and recommendation on the next practical step.
Timing: Same-day routing when possible.
What you get: Urgency assessment and recommended response path.
Limit: Legal representation and final filings are scoped separately if needed.

Send the emergency request or call the listed phone number.

Confidential intake

Use this form for 483 review, urgent help, or a scoped readiness assessment. Include the response date if FDA gave you one.